NZJ — Respirator, N95, For Use By The General Public In Public Health Medical Emergencies Class II

FDA Device Classification

Classification Details

Product Code: NZJ
Device Class: Class II
Regulation Number: 880.6260
Submission Type
Review Panel: HO
Medical Specialty: General Hospital
Implant: No

Definition

It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K083176	pasture pharma pte	PASTURE, MODELS: F550, A520	January 23, 2009
DEN060009	3m	3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR	May 8, 2007